Actively Recruiting
Comparative Study of Prednisolone and Cerebrolysin Treatments for Bell's Palsy
Led by October 6 University · Updated on 2025-07-31
90
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Bell's palsy is a common facial nerve disorder causing weakness or paralysis on one side of the face. This research evaluates the effects of two treatments, Prednisolone and Cerebrolysin, to study how well Cerebrolysin helps nerve regeneration compared to corticosteroids. The trial is a randomized, double-blind study sponsored by October 6 University, focusing on adults aged 18 to 60 years with acute unilateral facial palsy of unknown cause. Participants will be assigned to one of three treatment groups: Prednisolone alone, Cerebrolysin alone, or a combination of both. Prednisolone is given as a 60 mg tablet once daily for 5 days followed by a tapering dose, while Cerebrolysin is administered intramuscularly at 10 mg daily for 3 weeks. The study monitors changes in facial nerve function over three weeks using standardized grading systems. During the study, participants will be assessed at baseline, after 1 week, and after 3 weeks using the House-Brackmann and Sunnybrook grading scales to measure facial nerve recovery. Researchers will track progress and safety throughout the trial period. Total participation time includes initial screening and treatment phases, with follow-up evaluations to measure treatment outcomes and monitor for any complications.
CONDITIONS
Brief Title
Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years
- Unilateral acute facial palsy of no identifiable cause
You will not qualify if you...
- Recurrent facial Bell's palsy
- Pregnancy
- Diabetes
- Epilepsy
- Severe hypertension
- Renal or hepatic disease
- Gastric or duodenal ulcer
- Presence of acute otitis media or ipsilateral chronic otitis
- Recent head injury
- Psychiatric disease
- Contraindications for corticosteroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 weeks
Participants receive either Prednisolone tablets daily for 5 days with tapering dose or intramuscular Cerebrolysin daily for 3 weeks, or a combination of both.
Visits at baseline, after 1 week, and after 3 weeks (in-person)
Trial Site Locations
Total: 1 location
1
October 6 university hospital
Giza, Egypt, 12573
Actively Recruiting
Research Team
E
Engy Wahsh
M
mohamed rez
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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